The Effect of Experimental Neck Pain in Healthy Participants

Aalborg University40 enrolled

Overview

This study investigates if/how an experimentally applied muscle pain/soreness, lasting for some days may affect brain activity, balance, movement patterns, muscle function and pain sensitivity in a healthy population

All included healthy volunteers will participate in test-sessions on 4 separate days over approximately 2 weeks. During the study participants will be randomised into and either a control group (injection of isotonic saline into a neck muscle) or neck pain group (injection of Nerve Growth Factor (NGF) into a neck muscle). Alle participants tested with regards to: Brain activity related to neck muscles will be estimated using TMS Balance will be tested using a force place Body movements will be recorded using 3D tracking Muscle activity will be estimated using electromyography (EMG)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy Neck Pain

Interventions

Injection of Isotonic salineOTHER

Half the participants will be injected in a neck muscle with isotonic saline (Control group) and the other half will get NGF (Neck pain group).

Injection of NGFOTHER

Half the participants will be injected in a neck muscle with NGF (Neck pain group).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men and women aged 18-50 years * Only for sub-projects 1 and 2: Right-handed * Able to speak, read and understand Danish and English Exclusion Criteria: * Pain from the neck or shoulder area during the past 6 months * Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session * Former surgery in neck or shoulder * Current or previous chronic or recurrent pain condition * Pregnancy * Drug addiction defined as the use of cannabis, opioids or other drugs * Previous neurologic, musculoskeletal or mental illnesses * Regular use of analgesics * Abnormally disrupted sleep in the last 24 hours preceding the experiment * Lack of ability to cooperate * Unable to pass the TASS safety screening questionnaire for TMS

Locations (1)

Dept. Of Health Science and Technology, SMI, Aalborg University

Aalborg, Denmark

RECRUITING

Outcomes

Primary Outcomes

Change in pressure pain threshold (PPT) measured with a handheld pressure algometer

PPT will be assessed over head, neck, arm and leg sites.

Time frame: Day 0, 2,4 and 15

Change in motor evoked potentials

Trans cranial magnetic stimulation (TMS) is used to asses motor evoked potentials of neck muscles

Time frame: Day 0, 4 and 15

Change in Body movement

3D recordings of body movements

Time frame: Day 0, 4 and 15

Secondary Outcomes

Change in muscle activity (EMG)

EMG of axioscapular muscles \& trunk during arm movements

Time frame: Day 0, 4 and 15

Change in standing balance

Standing balance is measured on a force platform

Time frame: Day 0, 4 and 15

Change in perceived pain: McGill Pain Questionnaire

Pain will be scored using a scale from 0-10 with 0 being no pain and 10 being worst imaginable pain, by drawing on body charts and choosing words from the McGill Pain Questionnaire.

Time frame: Day 0, 2,4 and 15

Disability

Neck disability Index will be scored. Body movements will be scored on a modified 6-point Likert scale (0 = not difficult at all; 1 = minimally difficult; 2 = somewhat difficult; 3 = fairly difficult; 4 = very difficult; 5 = unable to perform)

Time frame: Day 0, 2,4 and 15

Pain Catastrophizing Scale (13 item questionnaire)

Central Contacts

Steffan W Christensen, PhD

CONTACT

+45 99408889 stc@hst.aau.dk

Data from ClinicalTrials.gov

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